Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

TAE - Bland embolization with 40-100 Microparticles performed via left transradial access

Radial TAE - Bland embolization with 40-100 Microparticles

TAE - Bland embolization with 40-100 Microparticles performed via right transfemoral access

Transfemoral TAE - Bland embolization with 40-100 Microparticles

EZIO LANZA, MD

The aim of this prospective, randomized study is to compare TRA vs TFA for superselective embolization of HCC using bland microparticles performed by multiple operators.

In particular, main objectives are to compare:

1. the success rates of TRA and TFA including crossing over events between techniques
2. the inter-operator outcomes in terms of time to complete the vascular access and the vessel catheterization
3. access-related adverse events
4. patient preference and reported discomfort

Hepatic arterial chemoembolization is a safe, proven, and effective technique for the treatment of a number of malignancies, including primary and secondary tumors \[1, 2\]. This endovascular treatment is performed via femoral artery access in most cases. In the last decades, the transradial approach (TRA) has emerged as a valid alternative to the transfemoral approach (TFA), and it is commonly used in coronary angioplasty as well as stent placement. In particular, shorter monitoring time after the procedure, earlier ambulation, shorter hospital stay and less discomfort associated with potentially reduced bleeding risks make TRA an attractive alternative to TFA.

To date, only one study exists comparing TRA vs TFA in liver embolizations \[3\]. However, it is non-randomized and reports only the outcomes of one operator performing lobar embolization for multiple liver malignancies.

The aim of this prospective, randomized study is to compare TRA vs TFA for superselective embolization of HCC using bland microparticles performed by multiple operators.

In particular, main objectives are to compare:

1. the success rates of TRA and TFA including crossing over events between techniques
2. the inter-operator outcomes in terms of time to complete the vascular access and the vessel catheterization
3. access-related adverse events
4. patient preference and reported discomfort

Radial Versus Femoral Access for Superselective Embolization of Hepatocellular Carcinoma

Questionnaire with four questions with 5 a points scale describing pain and discomfort during and after procedure, where 0 is the minimum and 4 the maximum.

Complication at the site of access like hematoma or pseudoaneurysm

Humanitas Clinical and Research Center

Antineoplastic Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Doxorubicin

Liposomal doxorubicin

Chlorotrianisene

The chemotherapy used in this arm is the Doxorubicin that will be carried into the tumor by Embozene TANDEM® (Boston Scientific) microspheres. TANDEM® embozene microspheres are made of non-resorbable, biocompatible, hydrogel microspheres, subjected to precision calibration and coated with an inorganic perfluorate polymer (Polyzene®-F)

The TAE will be performed with Embozene microspheres (Boston Scientific). Embozene microspheres are spherical particles of hydrogel, precisely calibrated, biocompatible, non-absorbable and coated with a perfluorinated inorganic polymer (Polyzene®-F)

The chemotherapy used in this arm is the Doxorubicin that will be carried into the tumor by Embozene TANDEM® (Boston Scientific) microspheres. TANDEM® embozene microspheres are made of non-resorbable, biocompatible, hydrogel microspheres, subjected to precision calibration and coated with an inorganic perfluorate polymer (Polyzene®-F).

TANDEM® embozene microspheres are available in three different sizes, in 2 ml and 3 ml volumes of product and are supplied in preloaded vials and syringes.The maximum loadable amount on the hydrospheres 50 mg of Doxorubicina for ml. The maximum injectable dose of Doxorubicin for each treatment is 150 mg and therefore the maximum amount of microspheres that can be used for each treatment is 3 ml. The size of microspheres that will be used in this study is up to 100 ± 25 μm.

DEB-TACE

The TAE will be performed with Embozene microspheres (Boston Scientific). Embozene microspheres are spherical particles of hydrogel, precisely calibrated, biocompatible, non-absorbable and coated with a perfluorinated inorganic polymer (Polyzene®-F). This medical device is available in various sizes; in this study, to avoid that the particle size exceeds the one used for the treatment of arm A, it will be possible to use microspheres with dimensions up to 100 μm (range 75 ± 125 μm).

Embozene microspheres are offered in vials containing 1 ml of suspended product in physiological saline solution for apyrogenic sterile transport. The total volume of the Embozene microspheres, including the transport solution, is about 7 ml. To this product it is necessary to add an appropriate amount of non-ionic contrast medium in order to obtain a homogeneous suspension and with good visibility during the injection under fluoroscopy.

Rita Golfieri, Professor

Developed in Japan in the 1980s, TACE became the most frequent treatment for unresectable hepatocellular carcinoma (HCC) in patients with preserved hepatic function after 2002, when two radiochemotherapies (RCTs) showed survival benefits for HCC patients who underwent conventional Lipiodol-based TACE (cTACE). Nowadays, nearly half of HCC patients undergo this procedure during their clinical history. In the last ten years, cTACE has been challenged by an alternative procedure, drug-eluting beads-TACE (DEB-TACE), after the introduction of calibrated embolizing microspheres loaded with a chemotherapeutic agent. DEB-TACE is considered to be less toxic and better standardized than cTACE, with reported no differences in patient survival. Since 2006, DEB-TACE has become the standard in many centers worldwide. Though, the need of adding doxorubicin to small beads embolization alone (TAE) remains unsettled. Though cTACE/DEB-TACE and TAE have been compared in several RCTs, no study demonstrated a clear survival benefit associated with the former.

Our study aims to compare first-line DEB-TACE and TAE on a random sample of HCC with the hypothesis that the addition of drug to embolization with small size beads is not associated with a survival benefit when compared to embolization alone performed with tiny calibrated microspheres. HCC is considered a chemo-resistant tumor and to date there is no clear evidence of benefits in associating anticancer agents to TAE. On the other hand, the optimal size of embolic agents has still to be defined. A comparative evaluation of TACE and TAE is essential for two additional reasons: a) it is still unclear whether side effects following embolization procedures are related to the embolization itself, to drug addition or both; b) DEB-TACE procedure is more expensive than TAE and, given the current attention on cancer-related health care cost control, identification of opportunities for cost savings in HCC treatments of an increasingly common cancer would be valuable.

Specific Aims

Specific aim 1 Compare time to progression (TTP) treated with TAE and DEB-TACE in a homogeneous hepatocellular carcinoma (HCC) patient population

Specific aim 2 Compare

* safety - severe adverse events (SAE)
* radiologic tumor response (mRECIST)
* overall survival (OS)
* cost-effectiveness after the entire follow-up

Study plan

Experimental design This is an interventional with drug, multicenter, prospective, randomized open label study.

Experimental design Aim 1 The study was designed, in relation to the primary endpoint, as an equivalence trial between two intra-arterial HCC treatments, i.e. DEB-TACE and TAE. The TTP considered as the reference value for the DEB-TACE arm is 9 months, on the basis of the results of our previous multicentric experience. The study is designed as an equivalence trial on the primary endpoint. The standard deviation of TTP is expected not to exceed 6 months, through accurate selection criteria of included patients. The equivalence limit is set to no more than 5 months between the two arms. Thus, using appropriate formulae each arm will be formed by 69 patients (alpha:0.05; beta:0.80). Taking into account a 10% of drop-out, the final sample size per each arm will be of 77 patients (154 total).

Experimental design Aim 2

* Safety. Adverse events (AEs) and severe adverse events (SAEs) will be monitored and recorded. AE will be assessed during and after each treatment and at all follow-up visits and graded according to the NCI Common Terminology Criteria for AE (CTCAE) version 3.0. The AEs occurring within 4 weeks after TACE will be considered as treatment related. SAE incidence in both arms will be ascertained assuming a reduction of SAE from 25% after TACE to 19% after TAE (25% of reduction). Such an assumption would require 607 patients per arm for being confirmed. To accomplish this task, the O'Brien-Fleming stopping boundaries will be applied considering an analysis when 69 patients for each arm will be obtained and follow-up ended. Applying stopping boundaries to this sample size, a nominal p-value \<0.001 (z-score: 3.15) is needed to confirm the assumption. If the p-value will be above this threshold (even if \<0.05) the null hypothesis will be not refused.
* Efficacy. The response will be evaluated by CT or MRI as local (per-lesion) response and overall (per-patient) response, according to mRECIST, at 1 month after each TACE and, thereafter, every 3 months, for at least 2 years.
* Survival. Through the selection previously described, we expected a standard deviation of the mean survival of no more than 10 months. To design the present equivalence trial we also expected a difference in the mean survival not greater than 5 months (equivalence limit) between the two groups. Using formulas proposed by Julious et al., each arm will be formed by 69 patients (alpha: 0.05; beta: 0.80). To obtain more robust estimate and accounting for possible dropout from the study a 10% of patients will be added to the initial sample size, resulting in 77 patients for each arm.
* Cost-effectiveness will be assessed from a third payer perspective, thus, including only direct costs of the procedures and related costs (hospitalization, imaging, etc.). The effectiveness will be assessed by measuring the life-expectancy. Incremental cost-effectiveness ratio (ICER) will be used to evaluate the cost-effectiveness of one treatment over the counterpart.

Study population The study involves the enrollment of a total of 154 patients, 77 per randomization arm, with a HCC diagnosis, according to the guidelines of the American Association for the Study of the Liver Disease (AASLD), as in clinical practice. The enrolled patients will have to meet the inclusion criteria and sign the informed consent for the participation in this study. At the time of enrollment, demographic, clinical and radiological data will be collected, as in standard clinical practice.

Treatment

Treatment study In the present study, only patients in the DEB-TACE arm (Arm A) will receive intra-arterial hepatic chemotherapy (Doxorubicin). Both treatment arms, on the other hand, will receive arterial embolization of the branches that vascularize the tumor lesions.

Arm A: DEB-TACE or chemoembolization with microspheres. The chemotherapy used in this arm is the Doxorubicin that will be carried into the tumor by Embozene TANDEM® (Boston Scientific) microspheres. TANDEM® embozene microspheres are made of non-resorbable, biocompatible, hydrogel microspheres, subjected to precision calibration and coated with an inorganic perfluorate polymer (Polyzene®-F). Thanks to their design, the microspheres can be loaded with drugs, such as doxorubicin, in order to administer a local, controlled and constant dose of the drug to the tumor sites affected after embolization.

TANDEM® embozene microspheres are available in three different sizes, in 2 ml and 3 ml volumes of product and are supplied in preloaded vials and syringes.The maximum loadable amount on the hydrospheres 50 mg of Doxorubicina for ml. The maximum injectable dose of Doxorubicin for each treatment is 150 mg and therefore the maximum amount of microspheres that can be used for each treatment is 3 ml. The size of microspheres that will be used in this study is up to 100 ± 25 μm.

Arm B: TAE or embolization with microspheres. The TAE will be performed with Embozene microspheres (Boston Scientific). Embozene microspheres are spherical particles of hydrogel, precisely calibrated, biocompatible, non-absorbable and coated with a perfluorinated inorganic polymer (Polyzene-F). This medical device is available in various sizes; in this study, to avoid that the particle size exceeds the one used for the treatment of arm A, it will be possible to use microspheres with dimensions up to 100 μm (range 75 ± 125 μm).

Embozene microspheres are offered in vials containing 1 ml of suspended product in physiological saline solution for apyrogenic sterile transport. The total volume of the Embozene microspheres, including the transport solution, is about 7 ml. To this product it is necessary to add an appropriate amount of non-ionic contrast medium in order to obtain a homogeneous suspension and with good visibility during the injection under fluoroscopy.

In enrolled patients, regardless of the treatment arm, the possible presence of extra-hepatic shunts, such as gastric and pulmonary arteries arising from the hepatic branches, should be appropriately assessed. As in standard radiological practice in case of intra-arterial hepatic treatments, if these shunts are macroscopically evident, the preventive closure of the same vessels will be evaluated, using the devices that will be more suitable on a case-by-case basis. If these shunts are not treatable by occlusive devices, the enrolled patient will not be treated in the clinical study and the patient will be considered as drop-out. Both treatments will be repeated "on demand" after demonstration to the imaging of the presence of vital tumor ie absence of complete response (complete response, CR) or in case of intrahepatic distal recurrence at follow-up.

Safety assessment The evaluation of the safety of the experimental treatment will consist in the monitoring and recording of AEs and SAEs.

Transarterial Embolization Alone Versus Drug-Eluting Beads Chemoembolization for Hepatocellular Carcinoma

Transarterial Embolization Alone Versus Drug-Eluting Beads Chemoembolization for Hepatocellular Carcinoma. A Randomized Controlled Trial

TTP since randomization, as recommended from expert panel opinion, after TAE and DEB-TACE

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Professor

Symptoms and General Pathology

Rare Diseases

Neoplasm Metastasis

Neuroendocrine Tumors

Neoplastic Processes

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

Hematinics

Gastrointestinal Agents

Somatostatin

Liver Extracts

Octreotide

Hormones

Hormone Antagonists

Patients in this arm receive systemic pharmacologic therapy alone

Patients in this arm receive systemic pharmacologic therapy and TAE

approved pharmacologic therapy

A Colao, M.D.

A Faggiano, M.D.

R D'Angelo, M.D.

F Fiore, MD

F Perrone, MD

C Gallo, MD

MC Piccirillo, MD

The purpose of this study is to verify if adding a locoregional treatment of liver metastasis (with trans-arterial embolization-TAE) to medical treatments of proven efficacy can prolong the progression free survival of patients affected by neuroendocrine tumors (NET) with inoperable liver metastases

Systemic Therapy With or Without Upfront Transarterial Embolization for Inoperable Liver Metastasis of Neuroendocrine Tumors

Randomized Phase 3 Trial Evaluating the Efficacy of Locoregional Treatment With Transarterial Embolization (TAE) for Liver Metastases, in Combination With Pharmacotherapy, in Patients With Neuroendocrine Tumor and Inoperable Liver Metastasis.

clinical factors will be explored in relation to patient outcomes

Federico II University

University of Campania "Luigi Vanvitelli"

National Cancer Institute, Naples

In patients randomized to receive the experimental therapy, transarterial embolization (TAE) treatments will be initiated within one week of randomization. Blunt embolization will be performed with LC beads with a maximum size of 700 µm. Microwave ablation (MWA) will be performed up to one month following randomization. The LC beads will be admixed with 8-15 mL of contrast and injected into the arterial branch at a rate of 1-2 mL/min. Treatment may be discontinued if any exclusion criteria develop in the patient or at the patient's request.

Microwave ablation (MWA) will be performed up to one month following randomization. Treatment may be discontinued if any exclusion criteria develop in the patient or at the patient's request. All operative MWAs will be performed in a laparoscopic or robot-assisted laparoscopic setting. All ablations will be guided by intraoperative ultrasound. Ablations will be performed with a 2.45-GHz generator with a 1.8-mm-diameter transcutaneous antenna.

In transarterial bland embolization, beads are delivered directly into the arterial vessels feeding the tumor, usually by a percutaneous coaxial catheter system guided by ultrasound or fluoroscopy through the common femoral artery.

Transarterial embolization

Microwave ablation is a form of thermal ablation used to treat cancer. In this procedure, electromagnetic waves in the microwave energy spectrum (300 MHz to 300 GHz) are applied to tumor tissue. The oscillation of polar molecules produces frictional heating, ultimately generating tissue necrosis within solid tumors.

Microwave Ablation

Dionisios Vrochides, MD PhD

This is a single-center, prospective RCT to study the effectiveness of TACE and MWA combination therapy with MWA monotherapy for the treatment of early HCC. Primary outcome is 2-year intrahepatic disease-free survival.

This single-center, prospective randomized controlled trial (RCT) is designed to compare the outcomes and clinicopathologic results of trans arterial embolization (TAE) and microwave ablation (MWA) combination therapy with MWA monotherapy for the treatment of early (stages 0 and A) hepatocellular carcinoma (HCC). The primary aim of this study is to test the following hypothesis: 2-year intrahepatic disease-free survival does not differ between patients receiving the experimental therapy (MWA + TAE) and patients receiving the standard therapy (MWA alone) as treatment for early stage HCC. Secondary aims are: 1) to determine the clinical feasibility of TAE + MWA in HCC patients with a small tumor burden using patient demographics and disease characteristic data and 2) to determine the effect of TAE on radiographic tumor characteristics in this patient cohort.

The primary outcome is 2-year intrahepatic disease-free survival, which is measured from time of randomization and is defined as the absence of local or regional recurrence of HCC as determined by diagnostic imaging. Local recurrence is defined as an enhancing lesion contiguous with the ablation zone that is present on subsequent imaging but was not present on the initial post-ablation scan. Regional recurrence is defined as hepatic recurrence that is not adjacent to the ablation site.

TAE and MWA Combination Therapy in Early-stage Hepatocellular Carcinoma

Transarterial Embolization and Microwave Ablation Combination Therapy in Early-stage Hepatocellular Carcinoma: A Randomized Trial

Defined as the absence of local or regional recurrence of hepatocellular carcinoma (HCC) as determined by diagnostic imaging

Defined as the absence of local or regional recurrence of hepatocellular carcinoma (HCC) from date of treatment until 2 years after that date as determined by diagnostic imaging

Wake Forest University Health Sciences

In patients randomized to receive the experimental therapy, transarterial embolization (TAE) treatments will be initiated within one week of randomization. Blunt embolization will be performed with LC beads with a maximum size of 700 µm. Microwave ablation (MWA) will be performed up to one month following randomization. The LC beads will be admixed with 8-15 mL of contrast and injected into the arterial branch at a rate of 1-2 mL/min. Treatment may be discontinued if any exclusion criteria develop in the patient or at the patient's request.

Transarterial embolization: In transarterial bland embolization, beads are delivered directly into the arterial vessels feeding the tumor, usually by a percutaneous coaxial catheter system guided by ultrasound or fluoroscopy through the common femoral artery.

Microwave Ablation: Microwave ablation is a form of thermal ablation used to treat cancer. In this procedure, electromagnetic waves in the microwave energy spectrum (300 MHz to 300 GHz) are applied to tumor tissue. The oscillation of polar molecules produces frictional heating, ultimately generating tissue necrosis within solid tumors.

TAE + MWA Combination Therapy

Microwave ablation (MWA) will be performed up to one month following randomization. Treatment may be discontinued if any exclusion criteria develop in the patient or at the patient's request. All operative MWAs will be performed in a laparoscopic or robot-assisted laparoscopic setting. All ablations will be guided by intraoperative ultrasound. Ablations will be performed with a 2.45-GHz generator with a 1.8-mm-diameter transcutaneous antenna.

Microwave Ablation: Microwave ablation is a form of thermal ablation used to treat cancer. In this procedure, electromagnetic waves in the microwave energy spectrum (300 MHz to 300 GHz) are applied to tumor tissue. The oscillation of polar molecules produces frictional heating, ultimately generating tissue necrosis within solid tumors.

MWA Monotherapy

Total

Age, Continuous

Sex: Female, Male

Race/Ethnicity, Customized

United States

Region of Enrollment

Consented Participants

Cirrhosis Present

Ascites Present

History of Hepatic Encephalopathy

History of Ascites

Please Note if any of the following are present (HCV, HPV, Heavy Alcohol use, drug use, nicotine use

Please Note if any previous treatment occured (colon: ablation, tace, chemo, embolization, resection

Please note any previous antiviral therapy the patient has received (IFN, PEG-IFN, Harvon, Other)

Method of diagnosis for HCC - CT

Method of diagnosis for HCC - MRI

Method of diagnosis for HCC - Biospy

Study closed early due to physician decision.

Blair Stephenson, Research Business Manager

The analysis population description is not available. This study was terminated 1 year and 10 months after the enrollment of the first patient. There was not enough funding the support this study, and the PI opted to terminate the study.

Intrahepatic Disease-free Survival

Overall Survival

Intrahepatic Disease-free Survival - 1 Year

Postoperative Morbidity

Postoperative Mortality

Overall Survival - 3 Years

Overall Survival - 5 Year

Intrahepatic Disease-free Survival - 2 Year

Intrahepatic Disease-free Survival - 3 Year

Intrahepatic Disease-free Survival - 5 Year

Overall Study

HCC after incomplete TAE or TACE treated by SBRT

HCC after incomplete TAE or TACE treated by a new cycle of TAE or TACE

Patients with single nodule no more 5 cm or 1- 3 nodules no more 3 cm in diameter after incomplete TAE or TACE, are randomized to stereotactic radiotherapy in 3 or 6 daily fractions

SBRT

Patients with single nodule no more 5 cm or 1- 3 nodules no more 3 cm in diameter after incomplete TAE or TACE, are randomized to a new cycle of TAE or TACE

TACE

The trial is a multicentre, prospective, randomised controlled, unblinded, parallel-group superiority trial of SBRT versus standard TAE/TACE for the curative treatment of inoperable HCC treated with a TAE/TACE incomplete cycle.

In this phase III study patients with inoperable HCC single nodule no more 5 cm or 1- 3 nodules no more 3 cm in diameter after incomplete TAE or TACE, are randomized to stereotactic radiotherapy in 3 or 6 daily fractions or to a new cycle of TAE or TACE. A total of 80 patients (40 in each arm) will be recruited into the trial over a 2 years period and will be randomised on an equal basis to either SBRT or TAE/TACE. The follow-up period will be finished 1.5 years after the final patient is randomised.

A Trial on SBRT After Incomplete TAE or TACE Versus Exclusive TAE or TACE For Treatment of Inoperable HCC

A Randomised Phase III Trial on Stereotactic Body Radiotherapy (SBRT) After Incomplete Transcatheter Arterial Embolization (TAE) or Chemoembolization (TACE) Versus Exclusive TAE or TACE for Inoperable Hepatocellular Carcinoma (HCC)

This is a study designed to evaluate the efficacy of SBRT in selected HCC patients with an incomplete response after TACE/TAE.

incidence of acute and late complications

Istituto Clinico Humanitas

Treatment of hepatic tumors using bead embolization.

Treatment of hepatic tumors using bead embolization

LC Bead LUMI has been designed as a radiopaque version of the LC Bead

LC Bead LUMI

Bradford J Wood, M.D.

Background:

Liver cancer begins in the cells of the liver. It can be treated with chemotherapy, radiation, or even a liver transplant. A less invasive treatment may be able to help some people with liver cancer. It is called percutaneous transarterial embolization (TAE). For TAE, a material is injected into blood vessels to block the blood flow that is feeding the tumor. Researchers want to test a new material for TAE that may shrink tumors and can be seen on x-ray and CT images. The embolization may sometimes be combined with thermal ablation, or cooking tumors with needles that deliver heat by electricity or microwave.

Objective:

To test an embolization material called an LC LUMI beads. To see if it can block blood vessels that provide blood to cancerous tumors and to see how the beads look on x-ray and CT images.

Eligibility:

Adults 18 85 years old who have been diagnosed with liver cancer

Design:

Participants will have routine blood tests, physical exams, and x-rays.

Participants will be screened with blood tests, physical exam, and medical history. They will have a computed tomography (CT) scan of the abdomen and pelvis. This will include a contrast drink and a contrast (dye) injected in the veins.

Participants will be admitted to the clinic. They will repeat the screening tests.

Participants may have other tests. These may include x-rays, other scans, or ultrasound.

Participants will be evaluated for general anesthesia.

They will get counseling about the procedure.

Participants will get anesthesia. The LC LUMI beads will be injected into blood vessels. The beads contain iodine, which makes them visible by x-ray and by a CT scan machine.

Participants will have follow-up visits for 12 months. They will have CT scans and/or other radiologic tests.

Background:

Hepatocellular Carcinoma (HCC) is the 3rd most common cause of cancer globally with an increasing incidence worldwide.

Management of hepatic malignancies from primary Hepatocellular Carcinoma (HCC) or metastatic disease involves a multidisciplinary approach of surgery and chemotherapy and in the case of HCC, transplant, anti-VEGF sorafenib, or local or regional image guided therapies.

Thermal ablation (RFA or MWA) and transarterial embolization (TAE) are minimally invasive image guided local or regional therapies that have been extensively studied for decades, and more recently and to a lesser extent have been studied together as a combination therapy.

LC Bead LUM\^TM, a radiopaque embolic bead product (company code BTG 13-002), is an imageable spherical embolic product that can be visualised by X-ray based imaging (e.g., fluoroscopy and CT).

The beads are non-resorbable microspheres with calibrated size ranges that occlude arteries for the purpose of blocking the blood flow to a target tissue.

LC Bead LUMITM are intended to be used for the embolization of hypervascular tumors and arteriovenous malformations (AVMs).

Objectives:

To determine the imaging characteristics of radiopaque beads including qualitatively comparing virtual and actual bead perfusion in the treatment of hepatic tumors using bead embolization.

Eligibility:

Treatment eligibility for TAE requires agreement between the Interventional Radiologist reviewing imaging and feasibility of TAE and the patient's NIH primary treatment team who will evaluate the patient's clinical parameters to undergo anesthesia and the TAE and or ablation procedure.

At least \>=18 years of age

Patients with pathologically proven, hepatic-dominant neoplasm.

The extent of hepatic metastases is \<50% of total hepatic volume.

Past treatment with Y90 must be 6 months from TAE treatment and liver function within NIH institutional limits

ECOG performance status \<=2

Patients must have normal organ and marrow function per laboratory parameters

Patients with minor allergies to iodine will also be excluded.

Design:

Number of Participants: 30

Recruitment Time Frame: approximately 2 years

Type of Study: Feasibility study

This is a pilot study to assess the characteristics of radio-opaque bland beads during TAE in the treatment of hepatic malignancies. Patients may also receive thermal ablation treatment in conjunction with TAE if clinically indicated, although comparison of bead treatment with or without thermal ablation is not part of the study s aim.

To compare virtual and actual perfusion characteristics of the LUMI radiopaque beads with CBCT and/or CT. Patients scans will be obtained per TAE standard of care schedule. Other imaging evaluation of this therapy may be performed at regular intervals following completion of treatment, and will be governed by standard conventional imaging regimen post treatment.

The choice of which combination of imaging (CT, Cone beam CT (CBCT), or fluoroscopy) and when to image, will be made by the clinical care team for the patient, based upon multidisciplinary recommendations and NIH Clinical Center customary use and standard of care, and will be purely clinical decisions (not research-related).

The participants will have a diagnosed hepatic malignancy, and be eligible to undergo transarterial embolization and thermal ablation under general anesthesia. The LC LUMI bead will be used in the transarterial embolization procedure.

Follow up will continue for 12 months from the time of initial treatment.

Patients will be evaluated in multidisciplinary GI medical oncology clinic and up to 30 patients will be enrolled to accrue 20 evaluable patients.

LC Bead LUMI Radio-Opaque Embolic Beads to Detect and Characterize the Vascularity of Hepatic Tumors During Treatment With Transarterial Embolization (TAE) Alone or Combined With Thermal Ablation

A Phase II Study Using LC Bead LUMI Radio-Opaque Embolic Beads to Detect and Characterize the Vascularity of Hepatic Tumors During Treatment With Transarterial Embolization (TAE) Alone or Combined With Thermal Ablation

.not yet known if there will be a plan to make IPD available

No statistical analysis is required to power this trial, as it is a pilot feasibility study, and the outcomes related to imaging features will not be statistically analyzed, other than simple descriptive statistics.

National Institutes of Health Clinical Center (CC)

Apatinib

Fluorouracil

Oxaliplatin

Protein Kinase Inhibitors

Enzyme Inhibitors

TAE+HAIC combined with camrelizumab and apatinib

TAE: 3-15ml iodized oil;

HAIC: Indurating arterial catheter, oxaliplatin 85mg/m\^2 D1, arterial infusion, lasting 1-2 hours (d1), LV 400mg/m\^2, arterial infusion, lasting 2-3 hours (d1), 5-Fu 400mg/m\^2, arterial infusion, lasting 3 hours (d1), and fluorouracil 2400 mg/m\^2 for 24-48h;

camrelizumab: 200mg, ivgtt, 30 min (not less than 20 min, not more than 60 min) every 3 weeks (21 days);

apatinib mesylate: 250mg, once a day, taken orally (the time of daily administration should be as much as possible), with warm water.Stop for 3 days before next cycle intervention.

Camrelizumab was given intravenously 1 day before TAE+HAIC treatment for each cycle, TAE+HAIC treatment was given on the second day, and oral apatinib was started after discharge.

camrelizumab

Yiping Chen

Zhong Tang

Yingchun Li

Peishu Huang

Lei Yu

To evaluate the efficacy and safety of TAE+HAIC combined with camrelizumab and apatinib in the treatment of advanced liver cancer with high tumor load

At present, there are no prospective clinical studies using the combination regimen (TAE+HAIC+ Apatinib + camrelizumab) in the treatment of advanced liver cancer. Therefore, in this study, investigators designed a single-arm, prospective, multicenter, phase Ⅱ clinical study of arterial infusion of TAE+HAIC+ Apatinib + camrelizumab in the treatment of advanced liver cancer with high tumor load, to explore the safety and efficacy of this regimen. If study gets positive results, it will provide a reference for the subsequent phase Ⅲ clinical trial design, which is expected to provide a new effective approach for the treatment of advanced liver cancer.

A Study of TAE+HAIC Combined With Camrelizumab and Apatinib in the Treatment of Advanced Hepatocellular Carcinoma

Single-arm, Prospective Clinical Study of TAE+HAIC Combined With Camrelizumab and Apatinib in the Treatment of Advanced Hepatocellular Carcinoma With High Tumor Load

Refers to the proportion of all subjects with a best overall result (BOR) of complete remission (CR) or partial remission (PR) as rated according to RECIST 1.1 criteria. If efficacy of CR or PR is achieved, subjects must be confirmed not less than 4 weeks ± 7 days after the initial evaluation.

Refers to the proportion of all subjects with a best overall result (BOR) of complete remission (CR), partial remission (PR), and stable disease (SD) as rated according to RECIST 1.1 criteria.

PFS was defined as the date from which the subject was first given medication to the date when tumor progression (as assessed by the criteria, with or without continued treatment) was first recorded or the date of death from any cause, whichever came first.

The definition refers to the time from randomization to the objective progression of the tumor, excluding "death."

Defined as the time between the date of first dose and the death of the subject due to all causes. Subjects who were alive at the last follow-up visit had OS counted as data censored at the time of the last follow-up visit. The OS of subjects who were lost to follow-up was counted as data censored at the time of last confirmed survival prior to the lost follow-up. OS for data censoring was defined as the time from first dose to censoring.

Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Radial Versus Femoral Access for Superselective Embolization of Hepatocellular Carcinoma	NCT03807947	Hepatocellular ... Hepatocellular ...	Radial TAE - Bl... Transfemoral TA...	40 Years - 90 Years	Humanitas Clinical and Research Center
Transarterial Embolization Alone Versus Drug-Eluting Beads Chemoembolization for Hepatocellular Carcinoma	NCT04803019	Carcinoma, Hepa...	DEB-TACE TAE	18 Years -	IRCCS Azienda Ospedaliero-Universitaria di Bologna
Systemic Therapy With or Without Upfront Transarterial Embolization for Inoperable Liver Metastasis of Neuroendocrine Tumors	NCT01755182	Neuroendocrine ...	approved pharma... TAE	18 Years - 80 Years	National Cancer Institute, Naples
TAE and MWA Combination Therapy in Early-stage Hepatocellular Carcinoma	NCT02704130	Hepatocellular ... Hepatoma Liver Cancer, A... Liver Cell Carc... Liver Cell Carc...	Transarterial e... Microwave Ablat...	18 Years - 75 Years	Wake Forest University Health Sciences
A Trial on SBRT After Incomplete TAE or TACE Versus Exclusive TAE or TACE For Treatment of Inoperable HCC	NCT02323360	Hepatocellular ...	SBRT TACE	18 Years - 95 Years	Istituto Clinico Humanitas
LC Bead LUMI Radio-Opaque Embolic Beads to Detect and Characterize the Vascularity of Hepatic Tumors During Treatment With Transarterial Embolization (TAE) Alone or Combined With Thermal Ablation	NCT02649868	Hepatic Cancer Liver Neoplasms Hepatocellular ... Liver Cancer	TAE RFA LC Bead LUMI	18 Years - 100 Years	National Institutes of Health Clinical Center (CC)
Transarterial Embolization Alone Versus Drug-Eluting Beads Chemoembolization for Hepatocellular Carcinoma	NCT04803019	Carcinoma, Hepa...	DEB-TACE TAE	18 Years -	IRCCS Azienda Ospedaliero-Universitaria di Bologna
A Study of TAE+HAIC Combined With Camrelizumab and Apatinib in the Treatment of Advanced Hepatocellular Carcinoma	NCT06363825	Advanced Hepato...	camrelizumab	18 Years - 80 Years	Fujian Medical University
A Study of TAE+HAIC Combined With Camrelizumab and Apatinib in the Treatment of Advanced Hepatocellular Carcinoma	NCT06363825	Advanced Hepato...	camrelizumab	18 Years - 80 Years	Fujian Medical University

Spots Global Cancer Trial Database for tae

Every month we try and update this database with for tae cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tae

Every month we try and update this database with for tae cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tae cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.